Evoke生理闭环脊髓刺激系统治疗慢性顽固性疼痛的设备简介:安全性和有效性概述。

IF 2.9 3区 医学 Q3 ENGINEERING, BIOMEDICAL
Expert Review of Medical Devices Pub Date : 2023-07-01 Epub Date: 2023-09-13 DOI:10.1080/17434440.2023.2255520
Lawrence Poree, Allison Foster, Peter S Staats
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引用次数: 0

摘要

简介:Evoke®脊髓刺激(SCS)设备能够对动态测量的诱发复合动作电位(ECAP)进行闭环反馈,以调整每个刺激脉冲的刺激幅度,从而将刺激输出水平保持在目标ECAP幅度附近。目前没有其他市售的SCS设备使用来自脊髓的生理反馈来调节刺激。临床医生应该熟悉设备的差异和最新技术,以提供优化的患者护理。涵盖的领域:在本设备简介中,对Evoke系统进行了描述,系统功能与其他可用的SCS设备有所不同。根据最佳实践指南进行了系统审查,以确定Evoke SCS系统安全性和有效性的所有可用证据。专家意见:Evoke SCS系统提供了独特的功能,可以优化针对每位患者的治疗方案。24个月随访的数据显示,Evoke系统治疗慢性顽固性疼痛的安全性和有效性具有统计学意义、临床意义、充分、一致和有力的证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Device profile of the Evoke physiologic closed-loop spinal cord stimulation system for the treatment of chronic intractable pain: overview of its safety and efficacy.

Introduction: The Evoke® spinal cord stimulation (SCS) device enables the closed-loop feedback of dynamically measured evoked compound action potentials (ECAPs) to adjust stimulation amplitude for every stimulation pulse to maintain the stimulation output level near a targeted ECAP amplitude. No other commercially available SCS device presently uses physiologic feedback from the spinal cord to adjust stimulation. Clinicians should be familiar with the differences in devices and with the latest technologies to provide optimized patient care.

Areas covered: In this device profile, the Evoke system is described and the system capabilities are differentiated from other available SCS devices. A systematic review was conducted based on best practice guidance to identify all available evidence on the safety and efficacy of the Evoke SCS system.

Expert opinion: The Evoke SCS system offers unique capabilities as a means to optimize therapy delivery tailored to each individual patient. Data through 24-months follow-up show statistically significant, clinically meaningful, ample, consistent, and strong evidence of the safety and efficacy of the Evoke system for the treatment of chronic intractable pain.

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来源期刊
Expert Review of Medical Devices
Expert Review of Medical Devices 医学-工程:生物医学
CiteScore
5.90
自引率
3.20%
发文量
69
审稿时长
6-12 weeks
期刊介绍: The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections: Expert commentary - a personal view on the most effective or promising strategies Five-year view - a clear perspective of future prospects within a realistic timescale Key issues - an executive summary cutting to the author''s most critical points In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.
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